510(k) · Cleared
ClearedLPG Therapeutic Massager, Models -Esi, Therapeutic Massager/Vibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lpg USA, Inc. · ISA Massager, Therapeutic, Electric
Cleared on Jan 18, 2000 as substantially equivalent to K850851 (Physio Technology, Inc., 1985) and 1 other predicate after a 342-day review. Its family tree reaches back 1 generation to 1985. 156 later devices descend from it.
- Decided
- Jan 18, 2000
- Review
- 342 days
- Class
- Class I
- Product code
- ISA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K850851 (1985). 2 ancestors in all. 156 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK850851 G5 Apparatus T, K1, K3 & the President Model'sPhysio Technology, Inc. · 1985
- This deviceK990445 LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/VibratorLpg USA, Inc. · 2000
- Descendant · cites it directly · 150 of its ownK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- Descendant · 2 generations on · 128 of its ownK070092 Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007
- Descendant · 2 generations on · 127 of its ownK071872 VelashapeSyneron Medical, Ltd. · 2007
- Descendant · cites it directly · 101 of its ownK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- Descendant · cites it directly · 95 of its ownK053611 SmoothshapesBicellulase, Inc. · 2006
Showing 5 of 156 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 156 · See all- K050397Velasmooth, ShaperSyneron Medical, Ltd. · 2005 · cites it directly150descendants
- K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007 · 2 generations on128descendants
- K071872VelashapeSyneron Medical, Ltd. · 2007 · 2 generations on127descendants
- K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008 · cites it directly101descendants
- K053611SmoothshapesBicellulase, Inc. · 2006 · cites it directly95descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850851 | G5 Apparatus T, K1, K3 & the President Model's | Physio Technology, Inc. | 1985 | — |
| 0 (this device) | K990445 | LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/Vibrator | Lpg USA, Inc. | 2000 | — |
| +1 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| +2 | K070092 | Modification to Velasmooth, Shaper | Syneron Medical, Ltd. | 2007 | — |
| +2 | K071872 | Velashape | Syneron Medical, Ltd. | 2007 | — |
| +1 | K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | Cutera, Inc. | 2008 | — |
| +1 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 14 | 0 |
| 2017 | 11 | 0 |
| 2018 | 3 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 12 | 0 |
| 2023 | 11 | 0 |
| 2024 | 12 | 0 |
| 2025 | 18 | 0 |
| 2026 | 11 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ISA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ISA device
- #1 K243488 Vmat Proscore 13.0 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K850851 | G5 Apparatus T, K1, K3 & the President Model'sSummary page 4…rapeutic Vibrators (21 CFR 890.5975). And as such Substantial Equivalence is also claimed to the following legally marketed devices, which are also Class 1. e (G5-GK1 - K850851 VIBRATOUCH™ 11 K912383 Table of Comparison Device Indications Design Specifications LPG Massager/Vibrator Minor muscle pain 5 m… | 1985 |
| * | K912383 | Vibratouch II Cordless Wand MassagerSummary page 4…CFR 890.5975). And as such Substantial Equivalence is also claimed to the following legally marketed devices, which are also Class 1. e (G5-GK1 - K850851 VIBRATOUCH™ 11 K912383 Table of Comparison Device Indications Design Specifications LPG Massager/Vibrator Minor muscle pain 5 models Ground current Re… | 1991 |
| * | — | LPG Therapeutic Massager Named without a submission number | |
| * | — | ES1 therapeutic massager Named without a submission number |
What descends from it? (156)
See all 1567 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K050397 (Syneron Medical, Ltd., 2005) has gone furthest, with 150 descendants of its own.
How does its category compare?
All ISA devicesISA Massager, Therapeutic, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ISA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ISA
Too few ISA 510(k)s in any year since 2007 to give a median.
Recalls per year · ISA
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ISA
16in 2025
MAUDE reports naming product code ISA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 1 | 10 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 3 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 2 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 8 |
| 2023 | 2 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 2 | 16 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Relieves minor muscles aches and pains
Relieve muscle spasm
Temporarily improves local blood circulation
Relieves minor muscle aches and pains, relieves pains, relieves muscle spasm and improves local circulation during burn rehabilitation
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990445: LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/Vibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990445
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026